QC Technical Specialist
QC Technical Specialist
- Helps maintain all QC Lab equipment in proper operational state, calibrated and qualified to include the equipment operating software packages.
- Perform a wide variety of activities to establish and ensure compliance with quality systems, quality procedures and policies and regulatory requirements to facilitate compliance with the agencies and customers.
- Provides training for new employees to the QC lab using approved documentation
- Develop, implement and maintain programs and processes to ensure high quality products and compliance with ICH, GMP, GLP and a safe & clean lab operation.
- Help with the maintenance of QC Lab documentation SOP’s, methodology, specifications, calibrations sheets, logbooks, etc. through change control, when needed.
- Lead or participate in focused deviation cross-functional investigations, improvement projects and other initiatives.
- Help identify Continuous Improvement Opportunities and perform their implementation.
- Implement management’s strategies and activities related to assuring compliance with regulations and ensure the company’s data integrity.
- Provide support for QC operations information during agency inspections as requested by QC manager.
- Manage ordering through SAP inventory management system.
- Investigate vendor options; ensure timely ordering procedures for consumable and chemical supplies; establish service contracts (such as for annual preventive maintenance of analytical instruments)
- In process samples testing record review and approval for release, when needed.
- Aid with retains & Stability testing program oversight, when needed.
- Quality systems support, including but not limited to: Investigation Support, Labeling, complaints, document control, training, CAPAs & Annual Product Reviews. When required.
- Participates in product development support, including but not limited to: Methodology Transfers, Stability program, project management, excel validations, oversight of special studies supporting regulatory filings and data/record retrieval for regulatory submissions.
- Prepare protocols, reports, metrics trend reporting, validation, logs & other documentation as needed.
- Help with review of manufacturing batch records.
- Other quality activities in support of the product as necessary & agreed upon.
- Working knowledge of laboratory instrumentation to include GC, ICP-MS, IR, Karl Fischer, PH, UV-VIS, Density, Auto-titration and Refractive Index.
- Experience in analytical method development, method transfer and validation.
- Experience in supporting FDA, EU, Corporate & other regulatory audits.
- Experience in writing SOPs, test methods and reviewing validation protocols in a pharmaceutical manufacturing laboratory environment.
- Experience with deviations, investigations & change controls.
- Proficiency with computer office tools (Word, Excel, LIMS, Outlook & scientific databases, etc.) is required.
- Ability to work in a fast paced environment and manage priorities & maintain timelines for multiple projects is essential.
- Knowledge of ICH, GLP & GMP guidelines & their applications.
- Needs to be highly motivated and flexible, with excellent problem solving skills.
- Advanced verbal, technical writing and interpersonal communication skills.
- S. in Chemistry or scientific discipline is required.
- Minimum 3 plus years’ experience working in a pharmaceutical QC manufacturing laboratory environment with emphasis utilizing Gas Chromatography.
- Strong documentation skills.
- Some knowledge of Pharmaceutical regulations & audit experience a plus.